SERVICES

CONSULTATION NEW & UPGRADED PROJECTS SUPPORT

Bridging expertise to guide your projects
Whether you need to update your Quality organization, reorganize
your teams, build a new plant, prepare inspections or develop a
specific project related to Quality, we have the key expertise to make it
a successful achievement.
Listening to stakeholder concerns and feedback is a valuable source
of information that we use to improve project design and outcomes.
• Undertake Feasibility studies to ensure cost effective
manufacture.
• Implementation of cost-effective, compliant quality
management systems
• Advice on legal and regulatory issues
• Assistance with responses to regulatory inspection reports

TRAINING & EDUCATION

AUDITING AND SUPPLIER EVALUATION

Our experts have over 20 years of experience in Quality auditing and
can perform a gap analysis of your organisation with respect to the
current standards.
This leads to regular action plans for improvement which Pharma
arena can manage depending on your objectives.
Our quality audits can help you in a crunch, or free up your valuable resources to focus on strategic core functionalities.
- Looking for a new reliable supplier of API, Starting or Raw Material?
- Looking for a partner to develop your business?
- Need a routine audit to fulfill your vendor management plan?
- Need to outsource auditing according to your process? Regular? On demand?

QUALITY VALIDATION & QUALIFICATION

Top Quality. Cost-effective. Result oriented
Pharma arena offers result oriented validation and regulatory affairs
solutions for companies seeking to obtain a competitive advantage
and compliance to various areas of GMP.
We have GMP consultants to work at your site under your direction on
short notice for short or long duration projects.
These include: Pharmaceutical Engineers, GMP compliance
consultants, Validation consultants, Regulatory Affairs
consultants and Technical document writers.
At Pharma arena, our goal is to help clients ensure their
facility, utilities, and equipment perform as intended.
We do that using a risk-based approach to maximize
time and cost efficiencies through focused qualification efforts.